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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04146363




Registration number
NCT04146363
Ethics application status
Date submitted
29/10/2019
Date registered
31/10/2019

Titles & IDs
Public title
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)
Scientific title
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
2019-002932-10
Secondary ID [2] 0 0
17801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Lebrikizumab
Other interventions - Placebo

Placebo comparator: Placebo - Induction Period (Baseline-Week 16):

Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Maintenance Period (Week 16-Week 52):

Two placebo SC injections as loading dose on Week 16 and Week 18. One placebo SC injection Q2W until Week 50.

Experimental: Lebrikizumab 250 Q2W - Induction Period (Baseline-Week 16):

500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.

Maintenance Period (Week 16-Week 52):

One 250 mg Lebrikizumab SC injection Q2W until Week 50.

For participants who received placebo in the Induction Period, the maintenance loading dose is:

Two 250 mg Lebrikizumab SC injections on Week 16.

Two 250 mg Lebrikizumab SC injections on Week 18.

To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is:

One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16.

One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.

Experimental: Lebrikizumab 250 Q4W - Maintenance Period (Week 16-Week 52):

One 250 mg Lebrikizumab SC injection every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48.

One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50.

For participants who received placebo in the Induction Period, the maintenance loading dose is:

Two 250 mg Lebrikizumab SC injections on Week 16.

Two placebo injections on Week 18.

To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is:

One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16.

Two placebo injections on Week 18

Experimental: Escape Arm (Lebrikizumab Q2W) - Maintenance Period (Week 16-Week 52):

Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion.

For participants who received placebo in the Induction Period, the loading dose is:

Two 250 mg Lebrikizumab SC injections on Week 16.

Two 250 mg Lebrikizumab SC injections on Week 18.

To maintain the loading dose blind, for participants who received Lebrikizumab in the Induction Period, the loading dose is:

One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.

For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.


Treatment: Other: Lebrikizumab
Subcutaneous injection

Other interventions: Placebo
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16
Timepoint [1] 0 0
Baseline to Week 16
Primary outcome [2] 0 0
Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (=75% Reduction in EASI Score) From Baseline to Week 16
Timepoint [2] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 2
Timepoint [1] 0 0
Baseline to Week 2
Secondary outcome [2] 0 0
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 4
Timepoint [2] 0 0
Baseline to Week 4
Secondary outcome [3] 0 0
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16 in Adults
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) From Baseline to Week 16
Timepoint [4] 0 0
Baseline to Week 16
Secondary outcome [5] 0 0
Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Percentage of Participants With a Pruritus NRS Score of =4-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Timepoint [6] 0 0
Baseline to Week 16
Secondary outcome [7] 0 0
Percentage of Participants With a Pruritus NRS Score of =5-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Timepoint [7] 0 0
Baseline to Week 16
Secondary outcome [8] 0 0
Percent Change in EASI Score From Baseline to Week 16
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Change From Baseline in Percent Body Surface Area (BSA) at Week 16
Timepoint [9] 0 0
Baseline, Week 16
Secondary outcome [10] 0 0
Percentage of Participants Achieving EASI-90 From Baseline to Week 4
Timepoint [10] 0 0
Baseline to Week 4
Secondary outcome [11] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Timepoint [11] 0 0
Baseline, Week 16
Secondary outcome [12] 0 0
Percentage of Participants Achieving =4 Point Improvement in DLQI From Baseline to Week 16
Timepoint [12] 0 0
Baseline to Week 16
Secondary outcome [13] 0 0
Percentage of Participants With a DLQI Total Score of =4-point at Baseline Achieving =4-point Improvement in DLQI From Baseline to Week 16
Timepoint [13] 0 0
Baseline to Week 16
Secondary outcome [14] 0 0
Percent Change in Sleep-loss Score From Baseline to Week 16
Timepoint [14] 0 0
Baseline, Week 16
Secondary outcome [15] 0 0
Change From Baseline in Sleep-loss Score at Week 16
Timepoint [15] 0 0
Baseline, Week 16
Secondary outcome [16] 0 0
Percentage of Participants With a Sleep-loss Score =2 Points at Baseline Who Achieve a =2 Points Reduction From Baseline at Week 16
Timepoint [16] 0 0
Baseline to Week 16
Secondary outcome [17] 0 0
Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1
Timepoint [17] 0 0
Baseline to Week 1
Secondary outcome [18] 0 0
Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2
Timepoint [18] 0 0
Baseline to Week 2
Secondary outcome [19] 0 0
Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4
Timepoint [19] 0 0
Baseline to Week 4
Secondary outcome [20] 0 0
Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1
Timepoint [20] 0 0
Baseline to Week 1
Secondary outcome [21] 0 0
Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2
Timepoint [21] 0 0
Baseline to Week 2
Secondary outcome [22] 0 0
Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4
Timepoint [22] 0 0
Baseline to Week 4
Secondary outcome [23] 0 0
Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
Timepoint [23] 0 0
Baseline, Week 16
Secondary outcome [24] 0 0
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab at Week 52
Timepoint [24] 0 0
Predose: Baseline, Week 4, Week 16, Week 32, Week 52
Secondary outcome [25] 0 0
Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continued to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)
Timepoint [25] 0 0
Baseline to Week 52
Secondary outcome [26] 0 0
Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a =2-point Improvement From Baseline at Week 16 Who Continue to Exhibit and IGA 0 or 1 and a =2-point Improvement From Baseline at Week 52
Timepoint [26] 0 0
Baseline to Week 52
Secondary outcome [27] 0 0
Percentage of Participants From Those With a Pruritus NRS of =4-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52
Timepoint [27] 0 0
Baseline to Week 52
Secondary outcome [28] 0 0
Percentage of Participants From Those With a Pruritus NRS of =5-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52
Timepoint [28] 0 0
Baseline to Week 52
Secondary outcome [29] 0 0
Percent Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52
Timepoint [29] 0 0
Baseline, Week 52
Secondary outcome [30] 0 0
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index
Timepoint [30] 0 0
Baseline, Week 16
Secondary outcome [31] 0 0
Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)
Timepoint [31] 0 0
Baseline, Week 16
Secondary outcome [32] 0 0
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
Timepoint [32] 0 0
Baseline, Week 16
Secondary outcome [33] 0 0
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents
Timepoint [33] 0 0
Baseline, Week 16
Secondary outcome [34] 0 0
Change From Baseline in PROMIS Depression at Week 16 - Adolescents
Timepoint [34] 0 0
Baseline, Week 16
Secondary outcome [35] 0 0
Change From Baseline in PROMIS Anxiety at Week 16 - Adults
Timepoint [35] 0 0
Baseline, Week 16
Secondary outcome [36] 0 0
Change From Baseline in PROMIS Depression at Week 16 - Adults
Timepoint [36] 0 0
Baseline, Week 16
Secondary outcome [37] 0 0
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma
Timepoint [37] 0 0
Baseline, Week 16
Secondary outcome [38] 0 0
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents
Timepoint [38] 0 0
Baseline, Week 16

Eligibility
Key inclusion criteria
* Male or female adults and adolescents (=12 years and =40 kg)
* Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit
* Eczema Area and Severity Index (EASI) score =16 at the baseline visit
* Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit
* =10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
* History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with dupilumab or tralokinumab
* Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
* Treatment with any of the following agents within 4 weeks prior to the baseline visit:

* Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
* Phototherapy and photochemotherapy (PUVA) for AD
* Treatment with the following prior to the baseline visit:

* An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
* Cell-depleting biologics, including to rituximab, within 6 months of baseline
* Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
* Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
* Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
* Evidence of active acute or chronic hepatitis
* History of human immunodeficiency virus (HIV) infection or positive HIV serology
* History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2022
Sample size
Target
Accrual to date
Final
424
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [3] 0 0
Skin & Cancer Foundation Australia - Westmead
Recruitment hospital [4] 0 0
The Skin Centre - Benowa
Recruitment hospital [5] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [6] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [7] 0 0
Emeritus Research - Camberwell
Recruitment hospital [8] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [9] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [10] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [11] 0 0
Burswood Dermatology - Victoria Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3053 - Carlton
Recruitment postcode(s) [9] 0 0
3002 - East Melbourne
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment postcode(s) [11] 0 0
06100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Estonia
State/province [22] 0 0
Tartu
Country [23] 0 0
France
State/province [23] 0 0
Cedex 10
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux Cedex
Country [25] 0 0
France
State/province [25] 0 0
Dijon Cedex
Country [26] 0 0
France
State/province [26] 0 0
Martigues
Country [27] 0 0
France
State/province [27] 0 0
Toulouse cedex 9
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Gyeonggi-do
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Korea
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Kyung Gi-Do, Korea
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Yongsan-gu
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Incheon
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Latvia
State/province [34] 0 0
Riga
Country [35] 0 0
Latvia
State/province [35] 0 0
Talsi
Country [36] 0 0
Lithuania
State/province [36] 0 0
Kaunas
Country [37] 0 0
Lithuania
State/province [37] 0 0
Vilnius
Country [38] 0 0
Poland
State/province [38] 0 0
Malopolska
Country [39] 0 0
Poland
State/province [39] 0 0
Malopolskie
Country [40] 0 0
Poland
State/province [40] 0 0
Mazowieckie
Country [41] 0 0
Poland
State/province [41] 0 0
Slaskie
Country [42] 0 0
Poland
State/province [42] 0 0
West Pomeranian
Country [43] 0 0
Poland
State/province [43] 0 0
Wojewodztwo Podkarpackie
Country [44] 0 0
Poland
State/province [44] 0 0
Katowice
Country [45] 0 0
Poland
State/province [45] 0 0
Krakow
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Poznan
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Poland
State/province [49] 0 0
Wroclaw
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Vizcaya
Country [52] 0 0
Spain
State/province [52] 0 0
Alicante
Country [53] 0 0
Spain
State/province [53] 0 0
Badalona
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Dermira, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04146363